Strategy for digitalization in GMP environment: The …...GMP environment Blue Ocean User adoption...
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#PIWorld ©2019 OSIsoft, LLC Strategy for digitalization in GMP environment: The Ferrer Group's journey Fernando Quintero Marc Olivé Torralba 1
Transcript of Strategy for digitalization in GMP environment: The …...GMP environment Blue Ocean User adoption...
#PIWorld ©2019 OSIsoft, LLC
Strategy for digitalization in GMP environment: The Ferrer Group's journey
Fernando Quintero
Marc Olivé Torralba
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#PIWorld ©2019 OSIsoft, LLC
Agenda
• Industry 4.0 project
•Project Challenges
•Results
•Future vision
PROPRIETARY AND CONFIDENTIAL© 2019 AG Solution – All rights reserved
AG Solution in a nutshell
AG Solution builds intelligent solutions for the process industry
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We offer customers a broad experience and high quality in building
• Automation Systems
• Process Control
• Data Management
• MES/MOM solutions
• Operational Intelligence
• Industry 4.0 consultancy
GREEN ENERGY,
BIO-GAS &
WASTE
TO ENERGY
ENERGY
PRODUCTION
&
DISTRIBUTION
SOLIDS & BULK
STORAGE
WATER
TREATMENT
&
DISTRIBUTION
FOOD &
BEVERAGE
CHEMICALS &
PETRO-CHEMICALS
LIFE SCIENCES,
PHARMA &
FINE
CHEMICALS
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Initial Business Case
Ferrer Group wanted to migrate their Historian to a modern, stable DataInfrastructure and fully compliant with regulatory norms.
Legacy
Historian
System✓ More Stability
✓ Capability to integrate several
Data Sources
✓ Improve procedures by
eliminating paper-based actions
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OSIsoft PI System
Alerts & notifications (process, maintenance)
Alarms&EventsData
Real Time Data
EBR Batch reporting
Exc. Review (RtReports)
Advanced analytics
Manual Data
Old hostorical data
OSIsoft PI Data Integration
Batch Data
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Creation of Plant Model
✓ AF model for asset supervision→
PI Notifications
✓ Integration with Batch System,
S88 based model with all recipe parameters
In Event Frames
→ EBR creation
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Quality improvements
Using RTReports:
Introduction of Review by exception
Full list of parameter deviations (with ST, ET)
Focus on deviations→
Time saving Quality procedures
EBR Creation
Batch reports with Recipe parameters
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Validation process
• Infrastructure Qualification
• Templates
• Training and support
• Time saving
• Optimal validation level
Advantages:
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GMP environment Joint effortBlue Ocean User adoption
Regulated environmentCompliance21 CFR part 11GAMP V
• IT• QA• Production• Engineering• Continuous
improvement• Management
and business
Industry 4.0 projects are still unknown in capabilities and benefits
• Introduction to a new system
• Understanding capabilities
• Resistance to change reduction
• Change in working conducts
Project challenges
Training and coaching!
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Final Project results
Initial objectives accomplished:
Installation of Data Infrastructure
Paper reduction
Data integrity
+ Improvements in:
Automation and operations improvement (alarm management, process control definition)
Quality system (review by exception), automation of quality supervision
Access to operational information
Reduction in operational mistakes
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Future vision
Explore new possibilities
• Alarm management (ISA 18.2)
• Introduction of new KPI’s (production, quality, performance)
• Group level expansion & roll-out
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CHALLENGES SOLUTION BENEFITS
The PI System allowed Interquim to digitalize their production
site by implementing EBR, all this by being fully compliant
with regulatory norms
Interquim road to continuous process awareness
▪ Paper reduction
▪ Data integrity
▪ Improvement of quality and production procedures
▪ User adoption
▪ Installation of Data infrastructure
▪ Integration will all operational data sources
▪ Creation of Data Context with PI AF
▪ System Validation (21 CFR part 11, GAMP V)
Improvement in:
▪ Automation and operations improvement
▪ Quality system (review by exception), Access to operational information
▪ Reduction of operational mistakes
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Thank You
LOS DATOS: LIFE SCIENCES 4.0 | RECETAS PARA LA FÁBRICA DEL FUTURO
LIFE SCIENCE, FOOD & BEVERAGE INDUSTRY FORUM
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Fernando QuinteroRegional Automation Manager | AG Solution
Marc Olivé TorralbaTechnical leader MES/MOM| AG Solution
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